Double Guidewire Technique Versus Transpancreatic Precut in Patients With Repetitive Unintentional Cannulation of the Pancreatic Duct.
试验速览
- 阶段
- 不适用
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Cannulation success
研究概览
简要总结
Difficult cannulation of the common bile duct is encountered in about 10%of ERCP procedures. This frequently happens in the form of repeated unintentional cannulation of the pancreatic duct. Two valid options are available to facilitate cannulation at this point: Double guidewire technique or performing a transpancreatic precut. This is a randomized trial comparing the efficacy and Safety of double guidwire technique versus transpancreatic precut after three unintentional passages of the guidewire into the pancreatic duct.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •unintentional cannulation of the pancreatic duct 3 times
- •Consenting to join the study
排除标准
- •Previous ERCP with or without previous sphincterotomy
- •Known coagulopathy
- •- Pregnancy
- •- Known acute pancreatitis at the time of procedure
结局指标
主要结局
Cannulation success
时间窗: Within 10 minutes
Proportion of patients with successful cannulation of the common bile duct
Rate of post-ERCP pancreatitis
时间窗: up to 24 hours after the procedure
Proportion of patients suffering post-ERCP pancreatitis
次要结局
- Time to successful cannulation(Within 10 minutes)